Z-2033-2017 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- May 10, 2017
- Initiation Date
- November 6, 2015
- Termination Date
- May 12, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 5,252 eaches
Product Description
Destination Renal Guiding Sheath Intended for the introduction of interventional and diagnostic devices into the human vasculature.
Reason for Recall
Based on internal investigation and testing that revealed the distal end of certain lots of Terumo Medical Destination¿ products may not contain the labeled 5 cm of coating. While there have been no complaints or patient related incidents reported, the lack of coating could render it difficult to navigate the device to the target vasculature.
Distribution Pattern
Nationwide Distribution.
Code Information
Terumo Product Code - RSR01 Affected Lot Numbers RN19 RN26 RP03